Intravascular Ultrasound-Guided PCI in Patients With Chronic Kidney Disease
IVUS-CKD
1 other identifier
interventional
1,528
1 country
1
Brief Summary
The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Jul 2024
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 23, 2024
June 1, 2024
2.9 years
July 10, 2024
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR)
The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups.
12 months
Secondary Outcomes (10)
Hierarchical composite of target vessel failure
12 months
30-day cardiorenal endpoint
30 days
Target vessel failure excluding periprocedural MI
12 months
Cardiac death
12 months
Target vessel MI
12 months
- +5 more secondary outcomes
Other Outcomes (9)
Renal outcomes
12 months
Annual change in eGFR from baseline
12 months
Clinically relevant bleeding
12 months
- +6 more other outcomes
Study Arms (2)
IVUS-guidance PCI
EXPERIMENTALIn the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment \> 5.0 mm\^2 or \> 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is \< 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm\^2 for the left main, greater than 7 mm\^2 for carina, greater than 6 mm\^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm\^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm\^2 for distal and greater than 8mm\^2 for proximal. Further treatment will be required if the criteria are not met.
Angiography-guidance PCI
ACTIVE COMPARATORAngiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis \< 20%.
Interventions
PCI with DES implantation
Eligibility Criteria
You may qualify if:
- CKD patients with eGFR\<60 mL/min/1.73 m\^2
- De novo coronary lesion suitable for second-generation metallic drug-eluting stent placement and IVUS imaging
- Signed written informed consent
You may not qualify if:
- Onset of STEMI within 24 hours or emergent angiography
- Pregnant or childbearing women
- Co-morbidity with an estimated life expectancy of \< 1 year
- LVEF ≤ 30%
- Cardiogenic shock or hemodynamic instability
- Severe hepatic dysfunction, defined as ALT or AST more than 5 times the ULN
- PCI within the previous 12 months
- Target lesion of stent thrombosis or in-stent restenosis
- Any planned non-cardiac surgery within 12 months
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
- Current enrolment in other clinical trials
- Contraindication to anti-platelet agents
- History of intracranial or gastrointestinal bleeding requiring transfusion or surgical intervention for control (excluding hemorrhoid)
- Chronic total occlusion lesion with unsuccessful guidewire crossing
- Current intake of nephrotoxic medications (e.g., nonsteroidal anti-inflammatory drugs except acetylsalicylic acid, phenylbutazone, aminoglycosides, amphotericin B, polymyxin, platinum complexes)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hopital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ning Guo
The First Affiliated of Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2024
First Posted
August 23, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 23, 2024
Record last verified: 2024-06